This webinar will explain the regulatory requirements and a risk-based procedure to qualify and manage suppliers that develop software for your company. The phases of the selection process, from compiling a list of candidate developers through the qualification audit and final decision, will be explained.
This process is based on the regulations and the authors experience in qualifying contract software developers. Contracts and Quality Agreements will be described in detail.
Why should you Attend: Regulatory agencies require that companies carefully select suppliers and contract software developers (CSD). They must follow a carefully planned and documented procedure. The responsibility for product quality and safety remains with the company. It cannot be delegated to the software developer.
Areas Covered in the Session:
Contract Software Developer risk determination method
Phases of selection
Developing the audit; key stakeholder issues
Conducting the audit; key points to evaluate
Decision factors for selection; key practical points
Reasons for not using a numerical scorecard to make a decision
Key points for the contract and Quality Agreement Change approval by both CSD and company
- Computer System Developers
- Systems Development Engineers
- QA/ QC
- Lab Managers and Analysts
- Production Managers
- Engineering Managers
• Computer System Developers
• Systems Development Engineers
• QA/ QC
• Lab Managers and Analysts
• Production Managers
• Engineering Managers